A Comparison of Two Metal Surface Finishes on Femoral Components in Hip Arthroplasty
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty|
- migration of femoral components evaluated by RSA
- BMD in the surrounding bone tissue of femoral components
|Study Start Date:||January 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
- Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
- Improve anchorage of the implant due to the higher friction coefficient
- Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116038
|Orthopaedic Center, Aarhus University Hospital,|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Kjeld Søballe, MD., Prof.||Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark|